UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of December, 2024
Commission
File Number: 001-38064
COSCIENS
Biopharma Inc.
(Translation
of registrant’s name into English)
c/o
Norton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibit
99.1 included with this Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statements on Form
S-8 (No. 333-224737, No. 333-210561, No. 333-200834 and No. 333-279844) (collectively, the “Registration Statements”) and
shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents
or reports subsequently filed or furnished. The information contained on any websites referenced in Exhibit 99.1 included with this Report
on Form 6-K is not incorporated by reference or deemed to be a part of this Report on Form 6-K or any of the Registration Statements.
Forward-Looking
Statements
The
information in this Report on Form 6-K and the exhibit attached hereto and incorporated herein by reference include forward-looking statements
within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, specifically Section 27A of the U.S. Securities Act
of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and under the provisions of Canadian securities
laws. These forward-looking statements involve a number of known and unknown risks, uncertainties and other factors that could cause
actual results and outcomes to be materially different from historical results or from any future results expressed or implied by such
forward-looking statements.
Forward-looking
statements include, but are not limited to, those relating to the Company’s expectations regarding the anticipated benefits and
synergies as well as the assets, cost structure, financial position, cash flows and growth prospects of the combined company.
Risks
and factors that could cause actual results or outcomes to differ materially from expectations include, among others, the following:
| ● |
the
Company’s patented technologies and value-driving products, and development thereof; |
| ● |
the
extraction, production and commercialization of active ingredients from natural sources and our ability to successfully market related
products; |
| ● |
the
successful development and marketing of our oat-based pipeline products, including oat-beta glucan, avenanthramides and beta glucan
from yeast, as well as such products’ capability to address unmet needs within the nutraceuticals markets; |
| ● |
Macrilen®
(macimorelin) and the Company’s plans in respect of same, including commercialization and clinical programs as well as in respect
of the top line data from the DETECT-trial; |
| ● |
the
Company’s business strategy; |
| ● |
the
strategic decision to sunset the Company’s Amyotrophic Lateral Sclerosis (ALS) program; |
| ● |
the
Company’s positioning in its target markets; |
| ● |
the
Company’s ability to accelerate the scale-up of PGX Technology towards commercial levels; |
| ● |
expectations
for completion of the Company’s Edmonton facility and Natex Termitz facility; |
| ● |
pre-clinical
and clinical studies and trials and their expected timing and results, including the potential to bring certain products to market
following such studies and trials; |
| ● |
the
ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications; |
| ● |
management’s
assumptions, estimates and judgements; |
| ● |
liquidity
and capital resources; |
| ● |
adequacy
of our financial resources to finance operations and expenditure requirements; |
| ● |
limitations
on internal controls over financial reporting; and |
| ● |
the
plans, objectives, future outlook and financial position of the Company in general. |
Additional
risk factors that could cause actual results to differ materially include those risks identified in Item 3. “Key Information –
Risk Factors” contained in the Company’s most recent Annual Report on Form 20-F filed with the SEC and its other filings
and submissions from time to time, including those containing its quarterly and annual results, with the SEC, which are available on
the Company’s website located at www.cosciensbio.com.
Many
of these risks and factors are beyond the Company’s control. The Company cautions you not to place undue reliance on these forward-looking
statements. All written and oral forward-looking statements attributable to the Company or persons acting on their behalf, are qualified
in their entirety by these cautionary statements. Moreover, unless required by law to update these statements, the Company will not necessarily
update any of these statements after the date hereof, either to conform them to actual results or to changes in their expectation.
DOCUMENTS
INDEX
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
| |
COSCIENS
Biopharma Inc. |
| |
|
|
| Date:
December 23, 2024 |
By: |
/s/
Giuliano La Fratta |
| |
|
Giuliano
La Fratta |
| |
|
Chief
Financial Officer |
Exhibit
99.1
COSCIENS
Biopharma Inc. Provides Corporate Update and Highlights Pipeline Prioritization
Company
leveraging core competencies to develop and commercialize
natural-based products to improve health and wellness
Streamlined
efficiencies and cost cutting measures taken to refine operations and development pathway forward
New
corporate presentation outlining key development areas to be available in January 2025
TORONTO,
ONTARIO, December 23, 2024 – COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”),
a specialty biopharmaceutical company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical
products, today provided a corporate update and reiterated its pipeline prioritization.
“Over
the course of the last several months following the merger, we have taken strategic and deliberate steps to evaluate and prioritize our
combined pipeline of products and programs. Through this effort, we have thoroughly evaluated the potential of our assets and prioritized
the areas that we believe are high-value opportunities, and we plan to move forward focusing our resources on advancing a pipeline of
natural-based products leveraging our core technologies. We believe that this focus, spanning cosmeceuticals, nutraceuticals and pharmaceuticals,
positions us with near and long-term life science growth drivers and the potential to become a global leader in natural-based products
for health and wellness,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS. “In addition, we have continued
to make progress driving revenues and growing our active ingredients base business. We are looking to kick off 2025 with a clear line
of sight towards execution of our business plan and believe we are well-positioned for a transformational year.”
Development
Projects Update
Pharmaceuticals:
| ● | Avenanthramides
Tablets (Avs) in Development as an Anti-Inflammatory: The Phase 1-2a clinical trial being
conducted at the Montreal Heart Institute has fully completed the Phase 1 part of the study
with 72 subjects tested. No significant side effects have been observed from ascending doses
ranging from 30 mg to 960 mg. The Company expects the Phase 2a efficacy study will be initiated
in Q1 2025, with expected completion in Q3 2025. |
Cosmeceuticals:
| ● | Enriched
Oat Flour with High Concentration of Avenanthramides: We have successfully produced and
sold small batches for inclusion in cream formulations. |
| | | |
| ● | JuventeDC
Product Line: New website, juventedc.com, was launched on December 19, 2024. |
Nutraceuticals:
| ● | Yeast
Beta Glucan (YBG) Powder - Immune Booster: Our YBG product has been successfully manufactured
as part of our PGX scale up project in Edmonton, Alberta. Our YBG product is being finalized
in capsule form with the goal to commercialize it as an immune booster in Q2 2025. |
| | | |
| ● | Oat
Beta Glucan (OBG) Chewable Bar – Cholesterol Reduction: We have successfully developed
a unique, standardized formulation for a healthy confection which includes a high concentration
of OBG with daily dosage according to approved claims in 10 developed countries. The substantive
claims include reduction of LDL cholesterol, supporting cardiovascular health reduction of
Type 2 diabetes risks, source of fiber for the maintenance of general good health and support
of a healthy digestive system. COSCIENS’ team anticipates the official commercial launch
of its chewable bar OBG natural health product in Q1 2025, marking an important chapter in
the Company’s journey toward promoting wellness while expanding its business model. |
Macimorelin:
| ● | On
August 27, 2024, the Company announced that the Phase 3 safety and efficacy study AEZS-130-P02
(the “DETECT-trial”) evaluating macimorelin for the diagnosis of Childhood Onset
Growth Hormone Deficiency (“CGHD”) had failed to meet its primary endpoints according
to the definitions in the study protocol. Based on the results of the study, we are prioritizing
our pipeline moving forward and repositioning the Company as a pure play Life Science’s
business offering natural-based products. Therefore, while maintaining the current commercial
indication for the use of macimorelin for the diagnosis of Adult Growth Hormone Deficiency
(“AGHD”), the Company has decided to not make any future investments in macimorelin
for the diagnosis of CGHD. Consequently, In order to further ensure the streamlining of operations
and reduce costs, the roles of some additional members of management have been terminated,
including Dr. Nicola Ammer, Chief Medical Officer, which will be ending on March 31, 2025. |
“On
behalf of the entire Board and Company, we are grateful to the members of the team for their years of dedicated service. Nicola has been
a long-standing, valued member of our team and provided years of expertise for the development of macimorelin (Macrilen®;
Ghryvelin®), the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis
of adult growth hormone deficiency. We are thankful to each member of our team and sincerely thank them for the key roles they played,”
concluded Mr. Gagnon.
The
Company plans to release a new corporate presentation outlining key development areas and upcoming milestones in January 2025.
About
COSCIENS Biopharma Inc.
COSCIENS
is a specialty biopharmaceutical company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and
pharmaceutical products. Our technology includes proprietary extraction technology, which is applied to the production of active ingredients
from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in
leading skincare product brands like Aveeno and Burt’s Bees formulations) and being developed as potential nutraceuticals and/or
pharmaceuticals. Our consolidated portfolio also includes macimorelin (Macrilen®; Ghryvelin®),
the first and only U.S. FDA and European Medicines Agency approved oral test indicated for the diagnosis of adult growth hormone deficiency
(“AGHD”).
The
Company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol “CSCI”.
For more information, please visit COSCIENS’ website at www.cosciensbio.com.
Forward-Looking Statements
Certain statements in this news release, referred
to herein as “forward-looking statements”, constitute “forward-looking statements” within the meaning of the United
States Private Securities Litigation Reform Act of 1995, as amended, and “forward-looking information” under the provisions
of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities,
or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as “anticipate”,
“assume”, “believe”, “could”, “expect”, “forecast”, “future”,
“goal”, “guidance”, “intend”, “likely”, “may”, “would” or the
negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify
forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements in this news release
include, but are not limited to, statements relating to: our goals and expectations regarding our plans related to the development, manufacture
or commercialization of our products, our plans to drive revenues from our products, our expectation we have the potential to become a
global leader in natural-based products for health and wellness.
Forward-looking
statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the
date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies
and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company
to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as
such, undue reliance must not be placed on them.
Forward-looking
statements involve known and unknown risks and uncertainties which include, among others: the combined Company’s present and future
business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions
and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in our revenue generation
from our marketed products, product development and related clinical trials and validation studies; results from our products under development
may not be successful or may not support advancing the product; the failure of the DETECT-trial to achieve its primary endpoint in CGHD
may impact the market for macimorelin (Macrilen®; Ghryvelin®) in AGHD and the existing relationships
we have for that product; ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence
on sales by and revenue from our main distributor of our legacy Ceapro products and its customers, the continued availability of funds
and resources to successfully commercialize our products; the ability to secure strategic partners for late stage development, marketing,
and distribution of our products; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements
with other pharmaceutical companies and keep such agreements in effect; our ability to protect and enforce our patent portfolio and intellectual
property; and our ability to continue to list our common shares on the NASDAQ Capital Market.
Investors
should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks
and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company’s profile on
SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties
or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or
developments, unless required to do so by a governmental authority or applicable law.
No
securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts
no responsibility for the adequacy or accuracy of this news release.
Issuer:
Gilles
R. Gagnon
President
& CEO
+1
(780) 421-4555
E:
ggagnon@cosciensbio.com
Investor
Contact:
Jenene
Thomas
JTC Team
T (US): +1 (908) 824-0775
E: csci@jtcir.com
COSCIENS Biopharma (NASDAQ:CSCI)
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